THERMOGARD 51-7310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405007449), received between Jan 4, 2016 and Jun 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Charred” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K140658); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2022Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE, 51-7310, THERMOGARD: DUAL FOIL, ADULT, WAS BEING USED FOR A LEFT CUBITAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿THE PAD WAS PLACED ON THE PATIENTS LEFT HIP. THE PROCEDURE WENT FINE, WHEN THE PAD WAS REMOVED THERE WAS A BURN NOTICED WHERE THE WIRE IS CONNECTED TO THE PAD. UPON VIEWING THE PAD FOR INSPECTION, THE WIRES WERE DISCONNECTED.¿ THERE WAS NO REPORT OF HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT THERE WAS NO PREPARATION OF THE PATIENT¿S SKIN PRIOR TO THE PAD APPLICATION. THE REPORT STATED THEY WERE UNABLE TO DETERMINE THE DEGREE OF BURN DUE TO THE ESCHAR ON THE TOP LAYER. WHEN ASKED IF THE DEVICE WIRES WERE ATTACHED PRIOR TO PLACEMENT THE REPORTER STATED THAT THERE WAS ¿NOTHING SEEN OUT OF THE NORM¿ WITH THE DEVICE. THE PATIENT WAS TREATED WITH OINTMENT AND A BANDAGE, THEN DISCHARGED WITH FOLLOW UP WITH PHYSICIAN. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 14563204 ↗
• InjuryJan 4, 2016Charred

  IT WAS REPORTED TO CONMED THAT DURING A LUMBARECTOMY PROCEDURE AN ADULT THERMOGARD DUAL FOIL DISPERSIVE ELECTRODE WAS PLACED ON THE PATIENT'S RIGHT SIDE LOWER ABDOMEN. SURGICAL STAFF DO NOT KNOW IF THE DISPERSIVE ELECTRODE WAS PLACED ON THE PATIENT BEFORE OR AFTER THE DISPERSIVE ELECTRODE WAS PLUGGED INTO THE ESU (ELECTROSURGICAL GENERATOR). IT WAS REPORTED THAT APPROXIMATELY TEN TO TWELVE MINUTES INTO THE CASE THE SURGICAL STAFF FELT, "SOMETHING WASN'T RIGHT". UPON CHECKING UNDER THE SURGICAL DRAPE IT WAS DISCOVERED THAT BURNING HAD OCCURRED AT THE DISPERSIVE ELECTRODE SITE AND THE PAD WAS COMPLETELY CHARRED. PER THE END-USER FACILITY THE PATIENT SUSTAINED THREE (3) SECOND DEGREE BURNS AT THE DISPERSIVE ELECTRODE SITE: TWO (2) PEA SIZED, AND ONE (1) QUARTER SIZED. NO PICTURES OF THE PATIENT BURNS WERE PROVIDED. A WOUND CARE DRESSING WAS APPLIED TO THE SITE. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 5340061 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140658. One submission often covers many models, so check the product and lot details in each record.

• Z-2599-2016 · May 18, 2016 · Terminated
  Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 75
• Z-2598-2016 · May 18, 2016 · Terminated
  Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 AB
• Z-2596-2016 · May 18, 2016 · Terminated
  Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical gene
• Z-2595-2016 · May 18, 2016 · Terminated
  Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurg
• Z-2597-2016 · May 18, 2016 · Terminated
  Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electr